Thursday, May 19, 2022

 

FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain

Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the time to resolve existing drug shortages. This is due, in part, to authorities the agency now has, including those added by the Food and Drug Administration Safety and Innovation Act

But despite mitigating or preventing hundreds of new drug shortages, disruptions in the U.S. drug supply continue to occur due to drug quality problems, vulnerabilities in the global supply chain, unanticipated increases in demand, market withdrawals of drugs or natural disasters.  

In 2019, in an effort to address the national drug shortage problem, the federal Drug Shortages Task Force released a report that called for the adoption of risk management plans to proactively assess risk and to predict and prevent supply disruptions that could potentially lead to a drug shortage. Then in 2020, Congress passed the CARES Act to require certain manufacturers to develop, maintain, and implement, as appropriate, risk management plans that identify and evaluate risks to a drug’s supply.

To further assist manufacturers with these requirements, we are issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to help with the development, maintenance and implementation of risk management plans.

The draft guidance describes a framework for stakeholders to consider when developing risk management plans that aligns with principles stated in the International Council for Harmonisation guidance for industry, Q9 Quality Risk Management, and identifies risk factors to consider when developing the content of risk management plans. The steps needed to reduce risks of a disruption in drug supply may vary among the different manufacturers in the supply chain for a given drug. 

Today’s draft guidance is an important step in what the nation needs to achieve an increasingly secure and resilient drug supply. For Americans to have access to an uninterrupted supply of safe, effective and high-quality drugs, all entities involved in the manufacture of a drug should take every step available to reduce risks and threats to the drug supply chain. Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages.

 

FDA's “All-in” Approach to Enterprise Transformation

The U.S. Food and Drug Administration's responsibilities to protect the public health are broad, complex, and necessary because the products we regulate are in every home and used every day across the U.S. As we witnessed during the pandemic, the FDA plays a critical role in enabling access to safe and effective medical products, such as vaccines, therapeutics, and accurate diagnostic testing. The agency also monitors and supports the supply chains for critical components of these products, while continuing to ensure the safety of our food supply, all in an increasingly complex and interconnected environment.

In meeting our public health mission, the FDA must have more effective and efficient business processes, increased capabilities to better use the data that we review, and a more coordinated development of the IT systems designed to support these activities. In the past, the FDA has taken an organization-based approach to process development and IT investments, resulting in siloed solutions and a fragmented data environment. To achieve new efficiencies, the FDA is advancing an agency-wide enterprise approach to business process, data, and technology management that will allow us to work more efficiently and optimize the use of the vast amount of data that is the foundation of our work.

Today we are introducing the Enterprise Modernization Action Plan, which is the next phase of the FDA’s stronger data and technology foundational approach.

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Meeting of the Pharmacy Compounding Advisory Committee ...

12 hours ago — June 8, 2022: Meeting of the Pharmacy Compounding Advisory Committee Meeting ... the list may specify that a drug may not be compounded in any for

 

 

 

New FDA Draft Guidance Aims to Increase Safety Information About Dietary Supplement Marketplace

Today, the U.S. Food and Drug Administration announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.

The FDA wants consumers who use dietary supplements to know that today’s draft guidance, if finalized, will advise the dietary supplement industry that the agency intends to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage manufacturers and distributors to correct any past failures to submit a required NDI notification. By providing industry with an opportunity to correct past failures to submit required safety information, the FDA can gain more safety information about the dietary supplement marketplace and better protect public health. 

“We remain committed to a flexible framework for dietary supplements that ensures the safety of these products for consumers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). “The resulting notifications the agency receives through this period of enforcement discretion will help increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace.” 

The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers and distributors who wish to market a dietary supplement containing an NDI to notify the FDA before marketing, unless a legal exception applies. The notification must contain the safety information that a manufacturer relied upon to conclude the dietary supplement containing the NDI is reasonably expected to be safe.  The NDI notification process is the FDA’s only chance to evaluate the safety of a dietary supplement before it becomes available to consumers.  For dietary supplements that do not contain an NDI, the law does not require manufacturers to submit safety information to the FDA before marketing.  The FDA is aware that in the more than 27 years since the requirement was established, some dietary supplement firms have marketed products for which a premarket NDI notification was required, but never submitted.

The enforcement discretion policy proposed in this draft guidance relates solely to the failure to submit an NDI notification. For example, it would not extend to NDI-containing dietary supplements that are adulterated for safety reasons or that violate any other regulatory requirements that pertain to dietary supplements. This temporary policy also should help facilitate enforcement actions against those that remain out of compliance with the NDI notification requirements after the enforcement discretion period ends.

In a February 2019 statement about new efforts to strengthen the regulation of dietary supplements through modernization and reform, the FDA emphasized the need to ensure that our regulatory framework is flexible yet comprehensive enough to effectively evaluate product safety, while promoting innovation. The FDA also stated that fostering the submission of NDI notifications would be key to this effort. This draft guidance is a critical first step toward encouraging those submissions.

If the draft guidance is finalized without change, the enforcement discretion period to submit a late notification would start when the guidance is published, would last 180 days, and would apply only to products on the market when the Federal Register notice announcing the draft guidance was published. Along with this draft guidance, the FDA is also developing a new submission type through the CFSAN Online Submission Module to provide a dedicated pathway for stakeholders to electronically submit their late notifications. 

Tuesday, May 17, 2022

 

FDA says microbial contamination found at Montana ...

6 days ago — The warning letter was issued to Montana Compounding Pharmacy and Wellness ... saying the company had continued to manufacture adulterated drugs even after ...

 

Horse of a different color: Peculiarities of equine pharmacology

by L Maxwell2015Cited by 4 — investigational drugs is often described in dogs before ... compounded drugs are often used. ... tions that specifically covered drug compounding too

 

Records: 2 people in execution knew drugs hadn't been tested

4 days ago — Compounded high risk sterile injectables such as those used in the Tennessee lethal injection protocol are extremely risky.” Smith was sentenced to death f

 

Compounded Nonsterile Preparations and FDA-Approved ...

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PCCA's compounding pharmacist members call on Congress ...

5 days ago — PCCA's compounding pharmacist members call on Congress to protect patient access to compounded medication. PCCA. Thu, May 12, 2022,

 

US Food and Drug Administration

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine. 

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, M.D. “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”   

On Jan. 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 12 through 15 years of age after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. Today’s action expands the use of a single booster dose of the vaccine for administration to individuals 5 through 11 years age at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine. The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 years of age and older and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in individuals 16 years of age and older.

“The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations. The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.”

Data Supporting Effectiveness

The EUA for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is based on FDA’s analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the October 2021 authorization of the Pfizer-BioNTech COVID-19 Vaccine primary series in this age group. Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose.

FDA Evaluation of Safety

The safety of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine in this age group was assessed in approximately 400 children who received a booster dose at least five months (range 5 to 9 months) after completing a two-dose primary series. The most commonly reported side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills and fever.

The FDA did not hold a meeting of its Vaccines and Related Biological Products Advisory Committee on today’s action, as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of Pfizer’s EUA request, the FDA concluded that the request did not raise questions that would benefit from additional discussion by committee members. The FDA will make available on its website relevant documents regarding today’s authorization. 

The amendment to the EUA was granted to Pfizer Inc.


 

FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program

Part of the U.S. Food and Drug Administration’s mission is to protect and promote public health by helping to ensure that safe, effective, quality drugs are available to patients. Drugs are not available to patients if they are in shortage. The 2019 report Drug Shortages: Root Causes and Potential Solutions found that a root cause of past drug shortages is that the market does not recognize and reward drug manufacturers that have invested in achieving quality management maturity (QMM). QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes in place to achieve quality objectives and promote continual improvement. Such business processes reduce the likelihood of supply disruptions and shortages.

To incentivize drug manufacturers to invest in QMM, the FDA has released a white paper that describes key considerations for measuring and rating a drug manufacturer’s quality management maturity, and their ability to deliver high-quality drugs reliably and without disruption. A QMM rating system could inform regulators and drug purchasers (e.g., distributors that ship drugs from manufacturers to pharmacies) about the performance and robustness of drug manufacturing facilities and give patients increased confidence in the availability of drugs. We are eager to engage with stakeholders on the development of a quality management maturity program and will be hosting a two-day workshop this month on May 24 and 25 for stakeholders to discuss their thoughts, perspectives and feedback.

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Wednesday, May 11, 2022

 

FDA compounding committee sets meeting | NCPA - National ...

5 days ago — FDA announced that the Pharmacy Compounding Advisory Committee will meet on June 8. The committee will discuss the following four bulk drug substances ..